Back in April, several of the outside experts brought in for an FDA panel session fretted over Astellas' mirabegron, an experimental drug for overactive bladder. The staff review had already raised serious questions about increased heart rates, along with painful rashes and anemia. But Astellas won the vote 7-4. And now it has gone on to pick up the formal approval.
The drug, now called Myrbetriq for marketing purposes, satisfies a key need for Astellas. Its blockbuster drug Vesicare loses patent protection in 2015. This new drug--which relies on a novel mechanism of action--can improve bladder storage, reducing patients' need to urinate frequently and often involuntarily. The market encompasses 33 million people, which is growing as the country ages.
To ensure that it's used safely, the FDA is restricting its use, cautioning against prescribing it for anyone with uncontrolled high blood pressure, for anyone with end-stage kidney disease or a major liver impairment. And Astellas plans to tout the oral drug as a significant improvement on existing meds.
"Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago," said Steven Ryder, president of Astellas Pharma Global Development. "The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health."
- here's the press release
- here's the Bloomberg report
Astellas scores FDA panel nod for overactive bladder drug